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FDA 510(k) Application Details - K000963
Device Classification Name
Stimulator, Electrical, Evoked Response
More FDA Info for this Device
510(K) Number
K000963
Device Name
Stimulator, Electrical, Evoked Response
Applicant
AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO, NY 14228 US
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Contact
PETER WEISENBORN
Other 510(k) Applications for this Contact
Regulation Number
882.1870
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Classification Product Code
GWF
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More FDA Info for this Product Code
Date Received
03/24/2000
Decision Date
10/20/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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